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Suppliers and packagers for generic pharmaceutical drug: PAZOPANIB HYDROCHLORIDE
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PAZOPANIB HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Apotex | PAZOPANIB HYDROCHLORIDE | pazopanib hydrochloride | TABLET;ORAL | 217713 | ANDA | Golden State Medical Supply, Inc. | 51407-872-12 | 120 TABLET in 1 BOTTLE (51407-872-12) | 2023-10-19 |
| Apotex | PAZOPANIB HYDROCHLORIDE | pazopanib hydrochloride | TABLET;ORAL | 217713 | ANDA | Apotex Corp. | 60505-4779-5 | 500 TABLET in 1 BOTTLE (60505-4779-5) | 2023-10-19 |
| Apotex | PAZOPANIB HYDROCHLORIDE | pazopanib hydrochloride | TABLET;ORAL | 217713 | ANDA | Apotex Corp. | 60505-4779-7 | 120 TABLET in 1 BOTTLE (60505-4779-7) | 2023-10-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Pazopanib Hydrochloride
Introduction
Pazopanib Hydrochloride, marketed under the brand name Votrient among others, is a targeted cancer therapy used primarily to treat advanced renal cell carcinoma, soft tissue sarcoma, and other malignancies. As a potent multi-targeted tyrosine kinase inhibitor, pazopanib interferes with tumor growth and angiogenesis. Due to its therapeutic importance, a comprehensive understanding of its suppliers is essential for pharmaceutical manufacturers, healthcare providers, and procurement entities aiming to ensure uninterrupted supply, quality, and compliance.
Manufacturers and Formulation Sources
Several pharmaceutical companies are authorized or capable of manufacturing pazopanib hydrochloride, either directly or through authorized licensing or co-development agreements. These suppliers can be categorized based on their roles:
1. Original Equipment Manufacturers (OEMs)
Manufacturers that produce the active pharmaceutical ingredient (API), pazopanib hydrochloride, often serve as the foundational source for brand and generic formulations.
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GlaxoSmithKline (GSK): Original developer of pazopanib, GSK initially patented and supplied the drug. While GSK's own manufacturing operations have been consolidated or licensed, their APIs and formulations have historically set the industry standard.
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Novartis and Other Major API Suppliers: Some global pharmaceutical companies and intermediaries have licensed or developed API manufacturing capabilities for pazopanib hydrochloride, often through complex supply agreements or licensing arrangements.
2. API Manufacturers and Suppliers
Key companies producing pazopanib hydrochloride API include:
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Hetero Labs Limited (India): One of the leading producers of generic APIs, including pazopanib hydrochloride, with WHO-GMP certification. Hetero's capacity is significant for global supply, especially for generic formulations.
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Copenhagen-based Lupin Limited: Known to produce and supply APIs for oncology drugs, including pazopanib hydrochloride, catering mainly to generics markets.
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Cayman Chemical (USA) and Meryx Biosciences: Smaller-scale or research-focused API suppliers, often providing initial batches or research quantities.
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Other Indian Manufacturers: Multiple Indian pharmaceutical companies, such as Natco Pharma and Dr. Reddy’s Laboratories, have developed manufacturing processes for pazopanib hydrochloride, either for proprietary use or generic licensing.
3. Contract Manufacturing Organizations (CMOs)
Third-party manufacturers often produce pazopanib hydrochloride under licensing agreements, ensuring scalability and compliance with good manufacturing practices (GMP). Noteworthy CMOs include:
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Strides Pharma Science Ltd. (India): Offers contract manufacturing and formulation services, including APIs.
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Viatris (formerly Mylan/Barlow): Engages in CMO services for oncology APIs, possibly including pazopanib hydrochloride.
Regulatory Approvals and Certification
Providers of pazopanib hydrochloride API must meet stringent regulatory standards, including WHO-GMP, US FDA, EMA, and other regional certifications. Suppliers with such accreditation are more reliable for pharmaceutical production, enabling compliance with international quality and safety standards.
Important Considerations:
- Quality Certifications: Ensure API suppliers possess current GMP, ISO, and domestic regulatory approvals.
- Traceability: Suppliers should provide batch records, stability data, and compliance documentation.
- Market Authorization: Some APIs are supplied under pre-approved licenses or via mutual recognition arrangements.
Distribution Channels and Importers
Major pharmaceutical traders and intermediaries facilitate the distribution of pazopanib hydrochloride API globally, especially in markets with high demand like India, China, Latin America, and Africa.
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Global Chemical and API Distributors:
- Aurochemicals Ltd.
- Kite Pharma Inc.
- Laurus Labs
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Regional Importers: Regional pharma traders often source APIs from Indian, Chinese, or European suppliers, depending on market-specific needs.
Impact of Patent and Licensing Status
While pazopanib hydrochloride remains under patent protection in specific regions, many manufacturers produce generic versions once patent exclusivity expires or under licensing agreements. This dynamic affects supplier landscape, enabling generic drug producers to access APIs legally and competitively.
Note: Patent expiration in key markets (e.g., 2021 in the US) has increased supply sources for pazopanib hydrochloride, intensifying competitive sourcing and potentially reducing costs.
Emerging Suppliers and Future Trends
The growing global demand for oncology therapeutics has incentivized new entrants into API manufacturing. Innovations such as continuous manufacturing processes and improvements in synthetic routes may diversify the supplier base further. Additionally, strategic alliances involving biotechnology firms and Asian manufacturers could expand supply options.
Conclusion
The supply landscape for pazopanib hydrochloride features a mix of original developers, established generic manufacturers—mainly Indian and Chinese companies—and a network of CMOs and distributors. Ensuring supply chain integrity involves selecting suppliers with proven regulatory compliance, robust manufacturing capacity, and transparent quality assurance practices.
Key Takeaways
- Diverse global suppliers, predominantly based in India and China, produce high-quality pazopanib hydrochloride APIs.
- Leading API manufacturers like Hetero Labs, Natco Pharma, and Lupin dominate the market, supported by stringent regulatory compliance.
- Contract manufacturing organizations augment supply capacity, especially for generic and emerging markets.
- Certification and traceability are critical in selecting suppliers to ensure regulatory compliance and product safety.
- The expiration of key patents has widened the supplier base, fostering competition and potentially reducing costs.
Frequently Asked Questions (FAQs)
1. Who are the primary global suppliers of pazopanib hydrochloride API?
Leading API producers include Hetero Labs (India), Lupin (India), Natco Pharma (India), and Chinese manufacturers like Shanghai Desano Pharmaceutical. These companies meet international GMP standards and supply both branded and generic medicines.
2. How can I verify the quality of pazopanib hydrochloride supplied by a manufacturer?
Request certification documents such as GMP certificates, stability data, batch release records, and FDA or EMA registration if applicable. Auditing the supplier or sourcing through reputable distributors also ensures quality.
3. Are there regional differences in pazopanib hydrochloride supplier availability?
Yes. India and China dominate global API production, offering cost-effective and high-volume options. Other regions have smaller, specialized manufacturers with localized supplies.
4. What should I consider when sourcing pazopanib hydrochloride APIs?
Assess regulatory compliance, manufacturing capacity, certificate authenticity, delivery timelines, and price competitiveness to ensure reliability and legal sourcing.
5. Are patent protections impacting the supplier landscape for pazopanib hydrochloride?
While patents initially restricted generic manufacturing, expiration in key markets like the US (2021) has enabled numerous generics from multiple suppliers, expanding the supply base.
References
- [1] GlaxoSmithKline. Votrient (Pazopanib) Overview. [Company Website]
- [2] US Food and Drug Administration. Approved Drugs Database.
- [3] Indian Drug Manufacturers' Association. API Market Reports.
- [4] World Health Organization. WHO-GMP Certified API Suppliers List.
- [5] Pharma Globally. API Supply Chain Insights.
Note: The information provided aims to facilitate procurement strategies and market analysis for pazopanib hydrochloride, highlighting the importance of regulated, quality-assured sources for sustainable access.
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